FDA approves Enroute TNS to restore blood flow to carotid arteries- Silk Road Medical

The FDA cleared for marketing, via Section 501 (k) procedure, the Enroute Transcarotid Neuroprotection System (Enroute TNS), for use during a minimally invasive procedure to restore normal blood flow to narrowed carotid arteries. It is the first device designed to access the carotid arteries through an incision in the neck, instead of the groin, and uses a blood flow reversal system to capture pieces of the blockage dislodged during the procedure.

Comment:

The new Silk Road procedure draws upon proven surgical techniques to protect the brain from stroke risk during carotid artery stenting. It allows physicians to deliver a stent directly from the neck, which is intended to avoid complications associated with starting from the femoral artery in the groin, which is typically used in carotid artery stenting procedures. To provide protection for the patient�s brain during the entire procedure, the Silk Road system temporarily reverses blood flow in order to move any debris away from the brain.

The trial showed that the rate of stroke, heart attack, and death among the ENROUTE TNS patients was 3.5 percent, significantly lower than the study performance goal of 11 percent. At least one serious adverse event occurred in 14.2 percent of patients, including excessive bleeding or injury at the device access site, low blood pressure due to the device or procedure, and blood clot formation within the placed stent. These events are consistent with the type and rate of serious adverse events associated with other carotid artery procedures.

Enroute TNS received CE Mark in July 2014.